FDA Information
Compatibility and fee information
A compatible iPhone® is required for hearing aid use. See fortell.com/compatibility for the list of compatible devices and operating system requirements.
There are no fees for using this app.
Warnings, cautions and notes
WARNING – Medical evaluation for people younger than 18
The user of a hearing aid in people younger than 18 years old without a medical evaluation may worsen impairment or disability. A prospective hearing aid user who is younger than 18 should have a recent medical evaluation from a doctor, preferable an ear-nose-throat doctor (an ENT). Prior to purchase, a doctor should determine that the person is a candidate for the user of a hearing aid.
WARNING: Hearing loss in people younger than 18
People younger than 18 should go to a doctor before using this. People younger than 18 years old need specialized care, and using this without a medical evaluation may worsen impairment or disability. A hearing aid user who is younger than 18 should have a recent medical evaluation from a doctor, preferably an ear-nose-throat doctor (an ENT). Before using this, a doctor should determine that the use of a hearing aid is appropriate.
WARNING – When to see a Doctor
If you have any of the problems listed below, please see a doctor, preferably an ear-nose-throat doctor (an ENT).
- Your ear has a birth defect or an unusual shape. Your ear was injured or deformed in an accident.
- You saw blood, pus, or fluid coming out of your ear in the past 6 months
- Your ear feels painful or uncomfortable.
- You have a lot of ear wax, or you think something could be in your ear.
- You get really dizzy or have a feeling of spinning or swaying (called vertigo).
- Your hearing changed suddenly in the past 6 months.
- Your hearing changes: it gets worse than gets better again.
- You have worse hearing in one ear.
- Your hear ringing or buzzing in only one ear.
WARNING to Hearing Aid Dispensers:
You should advise a prospective hearing aid user to consult promptly with a doctor, preferably an ear specialist such as an ENT, before dispensing a hearing aid if you determine through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions:
- Visible deformity of the ear, either congenital or traumatic
- Fluid, pus, or blood coming out of the ear within the previous 6 months
- Pain or discomfort in the ear
- History of excessive ear wax or suspicion that something is in the ear canal
- Dizziness, either recent or long-standing
- Sudden, quickly worsening, or fluctuating hearing loss within the previous 6 months
- Hearing loss or ringing (tinnitus) only in one ear or a noticeable difference in hearing between ears
- Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz
WARNING to Hearing Aid Dispenser, Outputs over 132 dB SPL:
You should exercise special care in selecting and fitting a hearing aid with a maximum output that exceeds 132 dB SPL because it may impair the remaining hearing of the hearing aid user.
Caution: This is not hearing protection.
You should remove this device if you experience overly loud sounds, whether short or long-lasting. If you’re in a loud place, you should use the right kind of hearing protection instead of wearing this device. In general, if you would use ear plugs in a loud place, you should remove this device and use ear plugs.
Caution: The sound output should not be uncomfortable or painful.
You should turn down the volume or remove the device if the sound output is uncomfortably loud or painful. If you consistently need to turn the volume down, you may need to further adjust your device.
Caution: You might need medical help if a piece gets stuck in your ear.
If any part of your hearing aid, like the dome, gets stuck in your ear, and you can’t easily remove it with your fingers, get medical help as soon as possible. You should not try to use tweezers or cotton swabs because they can push the part farther into your ear, injuring your eardrum or ear canal, possibly seriously.
Note: Ask about trial-rental or purchase-option programs.
If you’re unsure about your ability to get used to using a hearing aid, you should ask about a trial-rental or purchase-option program. Many hearing instrument specialists offer programs that allow you to wear a hearing aid for a short time, at a nominal fee, before you decide to buy the hearing aid.
Note: What you can expect when you start using a hearing aid
A hearing aid can benefit many people with hearing loss. However, you should know it will not restore normal hearing, and you may still have some difficulty hearing over noise. Further, a hearing aid will not prevent or improve a medical condition that causes hearing loss.
People who start using hearing aids sometimes need a few weeks to get used to them. Similarly, many people find that training or counseling can help them get more out of their devices.
If you have hearing loss in both ears, you might get more out of using hearing aids in both, especially in situations that make you tired from listening —for example, noisy environments.
Note: Tell FDA about any injuries, malfunctions, or other adverse events.
To report a problem involving your hearing aid, you should submit Information to FDA as soon as possible after the problem. FDA calls them “adverse events,” and they can include: skin irritation in your ear, injury from the device (like cuts or scratches, or burns from an overheated battery), pieces of the device getting stuck in your ear, suddenly worsening hearing loss from using the device, etc.
Instructions for reporting are available at https://www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088. You can also download a form to mail to FDA.
General warnings
For your safety and to ensure proper use, carefully review the following warnings before using your hearing aids and charging case. If your devices show unexpected behavior or you experience a serious incident, contact your hearing care professional. They can assist with troubleshooting and, if needed, reporting to the manufacturer or national authorities.
Hearing aids do not restore normal hearing and cannot prevent or improve hearing loss caused by natural processes such as aging or illness.
Hearing aids are only one part of hearing rehabilitation and may need to be supplemented with auditory training or instruction in lipreading.
To receive the full benefit, wear your hearing aids regularly.
Only charge your hearing aids with the designated charger. Using other chargers may damage the hearing aids or batteries.
This hearing aid contains a non-removable rechargeable lithium-ion battery. Always charge as directed and review the safety and handling information for rechargeable hearing aids.
Charging ports
Do not place anything other than rechargeable hearing aids in the charging ports. Other items may short circuit the charger and result in burns.
Usage of hearing aids
Hearing aids should only be used as directed by your hearing care professional. Misuse can result in sudden and permanent hearing loss. Never allow others to wear your hearing aids. Unauthorized use could cause permanent damage to their hearing.
Choking hazards of swallowing small parts
Keep all small parts (for example, hearing aids, earpieces, domes, etc.) out of reach and sight of children and others who might swallow these items. Seek emergency medical treatment immediately if someone is choking on small parts or batteries are swallowed.
If a hearing aid or small part is swallowed, see a doctor immediately and contact the National Poison Center at 1-800-222-1222 or National Battery Ingestion Hotline at 1-800-498-8666.
Strangulation hazards of cables
Keep all small cables out of reach of children and others who might become entangled with these items.
Keep away from environments with risk of explosions
Your hearing aids and charging case are safe to use under normal usage conditions. The hearing aids and charging case have not been tested for compliance with international standards concerning explosive environments.
Do not use the hearing aids or charging case in environments with danger of explosions such as mines, oil fields, oxygen rich environments or areas where flammable anesthetics are handled.
Do not attempt to open your hearing aids as it may damage the battery.
Never attempt to replace the battery. If battery replacement is needed, return your device to the supplier. The warranty is void if there are signs of tampering.
Never attempt to replace rechargeable batteries.
Never attempt to replace your charging case’s rechargeable batteries
Do not attempt to access your charging case’s battery as it may damage the battery.
Never attempt to replace the battery. If battery replacement is needed, contact Fortell. The warranty is void if there are signs of tampering.
Beware of battery leakage
Do not touch your hearing aids or charging case if the battery appears to be leaking as the acids may cause skin irritation. If you have been in contact with battery acids, wipe it off using a wet cloth. If you experience skin irritation, consult your doctor. In the event of battery leakage, contact Fortell for further instructions.
Connection to external equipment
The safety of recharging batteries using a USB-C connector is determined by the external signal source. Only use the originally supplied power brick when connecting the charging case to a power outlet.
Connecting the charging case to external equipment
You must use the USB-C wire and power brick supplied with your hearing aids. Do not attempt to connect your charging case using any other connector wire.
Beware of your surroundings
Do not use your charging case while driving or in other situations that require your full attention.
Beware of sudden dysfunction
Your hearing aids may stop working without notice. For example, if they run out of battery or if the receiver is blocked. Keep this in mind especially in situations where you depend on warning sounds (for example when in traffic).
Use with active medical implants
Your hearing aids have been thoroughly tested and developed for human health according to international standards for human exposure (Specific Absorption Ratio – SAR), induced electromagnetic power and voltages into the human body.
The exposure values are well below international accepted safety limits for SAR, induced electromagnetic power and voltages into the human body defined in the standards for human health and coexistence with active medical implants, such as pacemakers and heart defibrillators.
If you have an active brain implant, contact the manufacturer of your implanted device for information about the use with a hearing aid.
Your hearing aids and charging case contain magnets and should be kept at least 15 centimeters (6 inches) away from any implanted medical device. Follow the guidelines from the manufacturer of your implanted medical device regarding their use with magnets.
Use with cochlear implants
If you are using a cochlear implant (CI) on one ear and a hearing aid on the other ear, make sure to always keep your CI at least 1 centimeter (0.4 inches) away from your hearing aid. The magnetic field from the CI may permanently damage the speaker unit in your hearing aid. Never place the devices close together on a table (for example, when cleaning).
Do not carry the CI and the hearing aid together in the same box.
Detached dome in ear canal
Ensure that the dome is still connected to the receiver when removing the hearing aid from your ear. If the dome is not on the receiver, the dome may still be in the ear canal. Contact Fortell.
Remove hearing aids and charging case before certain medical procedures
Remove your hearing aids and charging case before medical procedures such as X-ray examinations, CT/MR/PET scans, electrotherapy, surgery, etc. Your hearing aids and charging case may be damaged if exposed to strong magnetic or electromagnetic fields.
Keep away from extreme heat
Never expose your hearing aids or charging case to extreme heat. For example, do not leave your hearing aids or charging case inside a parked car in the sun.
Never use an external heating device to dry your hearing aids or charging case. For example, do not dry your hearing aids or charging case using a hair dryer or in an oven such as a microwave.
Keep away from chemicals
Remove your hearing aids and keep your charging case at a safe distance before applying products that contain certain chemicals that can damage your hearing aids. For example, cosmetics, hairspray, perfume, aftershave lotion, suntan lotion and insect repellent. Allow the products time to dry before putting on your hearing aids.
Potential side effects
You may produce more earwax when using hearing aids. In rare cases, the non- allergenic materials in the product may cause skin irritation or other side effects. If you experience any such side effects, consult your doctor.
Transporting charger on aircraft
Consult the airline for details about bringing your charging case onto an aircraft.
Charge charging case every 3 weeks
Ensure you charge the charging case every 3 weeks to prevent potential battery damage during storage.
Use of third-party accessories
Only use accessories, cables or transducers supplied by Fortell. Non-original accessories may result in reduced electromagnetic compatibility (EMC) of your hearing aids.
Do not modify hearing aids
Do not make any modifications to your hearing aids not expressly approved by Fortell. This will void the warranty.
Should your hearing aid require service or replacement, contact Fortell for assistance. Many repair needs can be handled on-site at a Fortell clinic, and they will arrange for service if required.
Note
This device has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Hearing controls in the Fortell app
You can control your hearing aids from the Hear tab in the Fortell app. View the battery level, adjust the volume level, and change modes for both hearing aids.